NCT07213375

Brief Summary

The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobectomy/segmentectomy. The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in the morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Sep 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Sep 2025Nov 2026

Study Start

First participant enrolled

September 1, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

September 23, 2025

Last Update Submit

January 5, 2026

Conditions

AnalgeticLung Cancer (NSCLC)GlucocorticoidVideo Assisted Thoracic Surgery (VATS)

Keywords

Pain catastrophizingERASVATSLung cancerMinimizing pain

Outcome Measures

Primary Outcomes (1)

  • Pain when coughing on the morning of first postoperative day.

    The primary endpoint is pain when coughing on the first morning after surgery, measured on the NRS-scale (0-10; where 0 is no pain, and 10 is the worst possible pain).

    Morning of first postoperative day

Study Arms (2)

Low dose Dexamethasone (8mg)

ACTIVE COMPARATOR
Drug: Dexamethasone

High dose Dexamethasone (1mg/kg)

ACTIVE COMPARATOR
Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Patients will receive either low dose (8mg) or high dose (1mg/kg)

High dose Dexamethasone (1mg/kg)Low dose Dexamethasone (8mg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 year
  • Able to understand written and spoken Danish language
  • PCS ≥20
  • Signed written informed consent form.
  • Patient planned to elective VATS lobectomy/segmentectomy

You may not qualify if:

  • Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, ex-cluding inhaled steroids.
  • Individuals with diabetes requiring insulin treatment.
  • Pregnant or breastfeeding patients.
  • Patients with known allergies to the study drug.
  • Individuals with mental disabilities that may impair their capacity to provide informed consent or compromise the validity of data collection.
  • Patients with diagnosed schizophrenia, active psychosis, bipolar disorder, or a history of ongoing treatment with antipsychotic and/or antidepressant medications.
  • Individuals with altered pain perception due to other conditions or injuries, such as spi-nal cord or brain injuries, severe polyneuropathies, or neurological disorders.
  • Regular users of opioid medications.
  • Patients requiring reoperation within the first two postoperative days.
  • Individuals undergoing conversion to a surgical procedure other than VATS lobecto-my/segmentectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Cardiothoracic Surgery, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Lasse Visby, Medical Doctor

CONTACT

+4522246982lasse.visby@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 8, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

DK(1)